Further study details as provided by University of California, San Diego:

Primary Outcome Measures:

The primary outcome is the proportion of patients achieving a favorable outcome defined as Modified Rankin Scale score of 0 or 1, assessed 90 days after treatment. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The NIH Stroke Scale measure of neurologic deficit; the Barthel Index measure of activities of daily living; the Modified Rankin Scale measure of the degree of disability or dependence in daily activities [ Time Frame: 90 days ] [ Designated as safety issue: No ]

90 day mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]

A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain. Research has shown that tissue plasminogen activator (tPA)—a naturally occurring protein that opens blocked arteries by dissolving blood clots — activates the body's ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke.

The Food and Drug Administration (FDA) has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset.

Researchers believe that a lower body temperature (hypothermia) may be beneficial while a stroke is happening because hypothermia may prevent further brain injury, or may make the stroke less damaging.

Patients will receive a standard stroke evaluation, which includes blood tests, a computed tomography (CT) scan, complete physical and neurological examinations, and an electrocardiogram (EKG) to determine eligibility for the study.

There are two study groups - tPA alone or tPA with cooling (hypothermia). Participants will be randomly assigned to one of the two study groups. Length of participation (including observation after the patient leaves the hospital) is 90 days.

This study is part of the Specialized Program of Translational Research in Acute Stroke (SPOTRIAS), which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours, and finding ways to treat additional patients later.

NIHSS score ≥ 7 and ≤ 20 (right hemisphere) or ≥ 7 and ≤ 24 (left hemisphere) at the time of randomization

Pre-stroke mRS 0-1

Able to begin endovascular phase of hypothermia within 2 hours of tPA completion

Written Informed Consent, signed and dated by the patient (or patient's authorized representative)

Exclusion Criteria:

Etiology other than ischemic stroke

Item 1a on NIHSS > 1 at the time of randomization

Clinical symptoms consistent with brainstem or cerebellar stroke

Classic lacunar syndrome with imaging confirmation of small deep ischemia, but randomization will not be delayed for neuroimaging other than initial scan to exclude hemorrhage

Known contraindications to hypothermia, such as known hematologic dyscrasias that affect thrombosis (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans

Pregnancy (All women of child-bearing potential must have a negative pregnancy test, urine or blood, prior to therapy.)

Medical conditions likely to interfere with patient assessment.

Known allergy to meperidine or buspirone

Currently taking or used within previous 14 days MAO-I class of medication.

Life expectancy < 6 months

Not likely to be available for long-term follow-up

Use, or planned use, of intra-arterial thrombolysis, mechanical clot removal, or other experimental or approved acute therapy for this stroke event

Chest radiograph or clinical presentation suggestive of pneumonia at baseline.

Temperature upon admission greater than or equal to 38°C

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123161